Recruiting

Viome Nutritional Programs

Sponsor:

Viome

Code:

NCT05564273

Conditions

Metabolic Health

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

VIOME Precision Nutrition Program

VIOME-designed condition-based supplements

Study Details

Brief summary:

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will not utilize clinical sites.

Conditions

Metabolic Health

Study ID

NCT05564273

Start date

Oct 13, 2023

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Resident of the United States
  • Females and males ages 25-75 (inclusive)
  • Able to speak and read English
  • No unexplained weight loss, fevers, anemia, or blood in stool
  • Willing and able to follow the trial instructions, as described in the recruitment letter
  • Signed and dated informed consent prior to any trial-specific procedures.
  • Fasting insulin level >=15 uIU/mL or fasting glucose >= 100 mg/dL within the last 3 months, verified from medical records

Exclusion Criteria:

  • Unwilling to change current diet
  • Unwilling to go to Quest
  • Prior use of Viome products or services
  • Antibiotic use in the previous 4 weeks
  • Women who are pregnant (current or planned in the next 4 months), or breastfeeding
  • < 90 days postpartum
  • Active infection
  • Unable or unwilling to use Viome's App on an iPhone or Android smartphone
  • Significant diet or lifestyle changes in the previous 1 month
  • IBD diagnosis
  • Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
  • Cancer therapy within the previous 1 year
  • Major surgery in the last 6 months or planned in the next 4 months
  • Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
  • Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
  • Prescribed any drug(s) that may interact with the supplement formulations
  • Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:

Pregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD/NASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy

  • Allergies to any study-specific supplement ingredients
  • Currently on a specific diet:

FODMAP KETO PALEO

  • Gastrointestinal disease including:

  • GI surgery except:

  • Appendectomy and benign polypectomy
  • Esophagitis
  • Celiac disease
  • GI malignancy or obstruction
  • Peptic Ulcer Disease
  • Duodenal or gastric ulcer disease

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Placebo

Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis.

active comparator: Viome's Precision Nutrition Program

Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.

active comparator: Viome's condition-based supplements

Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis.

Interventions

VIOME Precision Nutrition Program

Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.

VIOME-designed condition-based supplements

Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.

Primary outcome measure

  • Efficacy of VIOME's designed condition based supplements (VCS) [ Time Frame: ~4months ]
  • Efficacy of VIOME Precision Nutrition Program (VPNP) [ Time Frame: ~4 months ]

Central Contacts and Locations

Central contacts

Locations

Viome Life Sciences

Recruiting

Bothell, Washington, United States, 98011

Contacts

Principal Investigator:

Momchilo Vuyisich, PhD

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • BMI
  • Framingham Risk Score
  • Insulin
  • blood glucose
  • HbA1c
  • hsCRP
  • Lipids
  • Supplements
  • Vitamins
  • diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.